Rituximab biosimilar, rixathon, given ‘positive opinion’ by the EMA CHMP for use in Follicular and Diffuse Large B-Cell Lymphoma, and Chronic Lymphocytic Leukemia

On the 21st April 2017, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for granting marketing authorization for rixathon, a rituximab biosimilar monoclonal antibody targeting CD20 in B-cells.

The marketing approval application for rixathon was submitted by Sandoz GmbH. The CHMP concluded that rixathon shows “comparable quality, safety, and efficacy to Mabthera® (rituximab)” from Roche.

Rixathon will be available as a 500mg and as a 100mg concentrate for solution for infusion. The full indications for rixathon are listed below:

Non-Hodgkin Lymphoma (NHL)

Rixathon is indicated for the treatment of previously untreated patients with stage III-IV FL in combination with chemotherapy

Rixathon maintenance therapy is indicated for the treatment of FL patients responding to induction therapy

Rixathon monotherapy is indicated for treatment of patients with stage III-IV FL who are chemo-resistant or are in their second or subsequent relapse after chemotherapy

Rixathon is indicated for the treatment of patients with CD20 positive DLBCL in combination with CHOP chemotherapy.

Chronic Lymphocytic Leukemia (CLL)

Rixathon in combination with chemotherapy is indicated for the treatment of patients with previously untreated and R/R CLL

Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rixathon or patients’ refractory to previous rixathon plus chemotherapy